Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of children with acute otitis media with otorrhea through tympanostomy tubes
Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of children with acute otitis media with otorrhea through tympanostomy tubes
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DOI：
10.1542/peds.113.1.e40
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发表时间：
2004-01-01
期刊：
影响因子：
8
通讯作者：
McLean, C
中科院分区：
文献类型：
--
作者：
Roland, PS;Kreisler, LS;McLean, C
Objective.目的比较环丙沙星/地塞米松耳用混悬液与氧氟沙星滴耳液治疗小儿急性中耳炎伴鼓膜穿孔的疗效和安全性。这项多中心、前瞻性、随机、双盲、平行组研究在39个研究中心对599名年龄大于或等于6个月至12岁、AOMT发作持续时间小于或等于3周的儿童进行。患者的平均年龄为2.5岁（标准差：2.37岁）。患者接受0.3%环丙沙星/0.1%地塞米松耳用混悬液4滴，每日2次，共7天或0.3%氧氟沙星耳用溶液5滴，每日2次，共10天。在第1天（基线）、第3天（治疗中）、第11天（治疗结束）和第18天（治愈测试）的临床访视时评价AOMT的临床体征和症状。使用患者日记测量至耳鸣停止的时间。主要病原菌为肺炎链球菌（16.8%）、金黄色葡萄球菌（13.0%）、铜绿假单胞菌（12.7%）、流感嗜血杆菌（12.4%）、表皮葡萄球菌（10.2%）、卡他莫拉菌（4.1%）。在治愈检验访视时，环丙沙星/地塞米松的临床治愈率（90% vs 78%）和微生物学成功率（92% vs 81.8%）上级氧氟沙星，治疗失败率更低（4.4% vs 14.1%），且至停止耳痛的中位时间更短（4天vs 6天）。环丙沙星/地塞米松治疗也上级优于访视时的临床应答改善、访视时的耳肿胀消失和访视时的耳肿胀体积减少。两种局部耳用制剂在儿科患者中均安全且耐受性良好。两种治疗方案均未观察到基于听力测试的言语识别阈值变化或听力较基线降低。外用环丙沙星/地塞米松治疗AOMT上级外用氧氟沙星。
Objective. To determine the efficacy and safety of topical ciprofloxacin/dexamethasone otic suspension compared with ofloxacin otic solution in the treatment of acute otitis media with otorrhea through tympanostomy tubes (AOMT) in pediatric patients.Methods. This multicenter, prospective, randomized, observer-masked, parallel-group study was conducted at 39 sites in 599 children aged greater than or equal to6 months to 12 years with an AOMT episode of less than or equal to3 weeks' duration. The mean age of patients was 2.5 years (standard deviation: 2.37 years). Patients received either ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension 4 drops twice daily for 7 days or ofloxacin 0.3% otic solution 5 drops twice daily for 10 days. Clinical signs and symptoms of AOMT were evaluated at clinic visits on days 1 (baseline), 3 (on therapy), 11 (end of therapy), and 18 (test of cure). A patient diary was used to measure time to cessation of otorrhea. Principal pretherapy pathogens included Streptococcus pneumoniae (16.8%), Staphylococcus aureus (13.0%), Pseudomonas aeruginosa (12.7%), Haemophilus influenzae (12.4%), S epidermidis (10.2%), and Moraxella catarrhalis (4.1%).Results. Ciprofloxacin/dexamethasone is superior to ofloxacin for clinical cure (90% vs 78%) and microbiologic success (92% vs 81.8%) at the test-of-cure visit, produces fewer treatment failures (4.4% vs 14.1%), and results in a shorter median time to cessation of otorrhea (4 days vs 6 days). Ciprofloxacin/dexamethasone treatment is also superior to improvement in clinical response by visit, absence of otorrhea by visit, and reduction of otorrhea volume by visit. Both topical otic preparations are safe and well tolerated in pediatric patients. No change in speech recognition threshold or decrease in hearing from baseline, based on audiometric testing, was noted with either regimen.Conclusion. Topical ciprofloxacin/dexamethasone treatment is superior to topical ofloxacin in the treatment of AOMT.